Mavorixafor Clinical Trials

Size	Price	Qty
5mg	USD 159
25mg	USD 477

Clinical Trials

Mavorixafor has been evaluated across multiple clinical trials spanning Phase I through Phase III to investigate its therapeutic potential in rare immunologic, hematologic, and infectious conditions, including WHIM syndrome, chronic neutropenia, Waldenstrom's macroglobulinemia, HIV, hepatic insufficiency, and healthy volunteers. Sponsored by pharmaceutical entities such as X4 Pharmaceuticals alongside public bodies like the National Institute of Allergy and Infectious Diseases, these studies encompass active non-recruiting, recruiting, and completed stages. The development program features pivotal Phase III research in WHIM syndrome.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06056297	RECRUITING	Neutropenia	X4 Pharmaceuticals	2024-06-06	PHASE3
NCT06858696	COMPLETED	Hepatic Insufficiency	X4 Pharmaceuticals	2025-02-28	PHASE1
NCT03995108	COMPLETED	WHIM Syndrome	X4 Pharmaceuticals	2019-10-24	PHASE3
NCT06914869	COMPLETED	Healthy Participants	X4 Pharmaceuticals	2025-02-18	PHASE1
NCT04154488	COMPLETED	Neutropenia	X4 Pharmaceuticals	2021-10-16	PHASE1; PHASE2
NCT04274738	COMPLETED	Waldenstrom's Macroglobulinemia	X4 Pharmaceuticals	2020-04-30	PHASE1
NCT03005327	COMPLETED	WHIM Syndrome	X4 Pharmaceuticals	2016-12	PHASE2
NCT04154488	Active not recruiting	Neutropenia	X4 Pharmaceuticals	2020-10-16	Phase 1\|Phase 2
NCT04274738	Completed	Waldenstrom''s Macroglobulinemia	X4 Pharmaceuticals	2020-04-30	Phase 1
NCT03995108	Active not recruiting	WHIM Syndrome	X4 Pharmaceuticals	2019-10-24	Phase 3
NCT00063804	Completed	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)\|Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections		Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-06)

Check the Mavorixafor product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mavorixafor (AMD-070) is a potent, selective CXCR4 antagonist that inhibits 125I-SDF binding with an IC50 value of 13 nM, thereby blocking downstream chemokine receptor signaling and intracellular pathway activation. By suppressing CXCR4-mediated chemokine signaling, Mavorixafor disrupts cellular retention mechanisms in the bone marrow, promoting leukocyte trafficking into peripheral blood to address pathobiology in WHIM syndrome, neutropenia, and Waldenstrom's macroglobulinemia.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).